SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) today confirmed that two Japanese regenerative medicine laws, which went into effect on November 25, 2014, remove regulatory uncertainties and provide a clear path for the Company to commercialize and market Cytori Cell Therapy™ and its Celution® System under the Company’s existing and planned regulatory approvals.
“Japan’s new regenerative medicine laws substantially clarify regulatory ambiguities of pre-existing guidelines and this news represents a significant event for Cytori,” said Dr. Marc Hedrick, President & CEO of Cytori. “We have a decade of operating experience in Japan and Cytori is nicely positioned to see an impact both on existing commercial efforts and on our longer-term efforts to obtain therapeutic claims and reimbursement for our products.”
Under the two new laws, Cytori believes its Celution System and autologous adipose-derived regenerative cells (ADRCs™) can be provided by physicians under current Class I device regulations and used under the lowest risk category (Tier 3) for many procedures with only the approval by accredited regenerative medicine committees and local agencies of the Ministry of Health, Labour and Welfare (MHLW). This regulatory framework is expected to streamline the approval and regulatory process and increase clinical use of Cytori Cell Therapy and the Celution System over the former regulations.
“Before these new laws were enacted, the regulatory pathway for clinical use of regenerative cell therapy was ‘one-size-fits-all,’ irrespective of the risk posed by certain cell types and approaches,” said Dr. Hedrick. “Now, Cytori’s point-of-care Celution System can be transparently integrated into clinical use by providers under our Class I device status and the streamlined approval process granted to cell therapies that pose the lowest risk. Our technology is unique in that respect.”
Cytori’s Celution System Is in Lowest of Three Risk Categories
The Act on the Safety of Regenerative Medicines and an amendment of the 2013 Pharmaceutical Affairs Act (the PMD Act), collectively termed the “Regenerative Medicine Laws,” replace the Human Stem Cell Guidelines. Under the new laws, the cell types used in cell therapy and regenerative medicine are classified based on risk. Cell therapies using cells derived from embryonic, induced pluripotent, cultured, genetically altered, animal and allogeneic cells are considered higher risk (Tiers 1 and 2) and will undergo an approval pathway with greater and more stringent oversight due to the presumed higher risk to patients. Cytori’s Celution System, which uses the patient’s own cells at the point-of-care, will be considered in the lowest risk category (Tier 3) for most cases, and will be considered in Tier 2 if used as a non-homologous therapy.
Streamlined Regulatory Approval for Certain Medical Devices
In the near future, Cytori intends to pursue disease-specific or therapeutic claims and reimbursement for Cytori’s Celution System and the Company would, at that point, sponsor a clinical trial to obtain Class III device-based approval and reimbursement. The new laws include changes to streamline regulation of Class II and some Class III devices, which will now require the approval of certification bodies rather than the PMDA, similar to the European ‘notified body’ model. To date, certification bodies have only been used for some Class II devices.
Conditional Regulatory Approval and Reimbursement Potential
As a supplementary benefit to Cytori, the Company may also choose to take advantage of the new ‘conditional approval’ opportunities granted under the new laws. Once clinical safety and an indication of efficacy are shown, sponsors may apply for their cell product to receive conditional approval for up to seven years and may be eligible for reimbursement under Japan’s national insurance coverage. Under the conditional approval, the sponsor can then generate post-marketing data to demonstrate further efficacy and cost effectiveness.
One-Year Implementation Period
Japan’s Regenerative Medicine Laws have a one-year implementation that allows medical institutions already providing regenerative medicine therapies under the pre-existing Human Stem Cell Guidelines to comply with the new laws by November 25, 2015.
“We enthusiastically applaud the Japanese scientific and political communities for their leadership in the field of regenerative medicine and cell therapy. These significant legislative and regulatory actions demonstrate that Japan is a leader in healthcare innovation and quality,” said Mr. Kenneth Kleinhenz, Cytori Vice President for Global Regulatory Affairs. “We have over 40 Celution systems already in use in Japan and we plan to continue our close work with providers to ensure rapid transition to the new laws and expansion of opportunities to help patients who can benefit from our products.”
About the Celution System
Cytori’s Celution system extracts a patient’s adipose-derived regenerative cells (ADRCs) and stem cells from the patient’s own adipose tissue and uses those purified cells to treat the patient or stores the cells for the patient’s future use.
About Cytori Therapeutics, Inc.
Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs®) to treat a variety of medical conditions. Multiple scientific publications suggest that Cytori Cell Therapy and ADRCs improve blood flow, moderate the inflammatory response and facilitate wound repair. As a result, we believe these cells can be applied with success across multiple disease states. These therapies are made available to the physician and patient at the point-of-care by Cytori’s proprietary technologies and products, including the Celution® System product family. For more information: visit www.cytori.com or follow on Twitter www.twitter.com/cytori.
Cautionary Statement Regarding Forward-Looking Statements
This communication includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding our understanding of the potential significance of the new Regenerative Medicine Law, are forward looking statements. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks include regulatory uncertainties in the application of the new law, the challenges inherent in convincing physicians and patients to adopt the new technology, dependence on third party performance, performance and acceptance of our products in the marketplace, and other risks and uncertainties described under the “Risk Factors” in Cytori's Securities and Exchange Commission Filings, including in its most recent annual and quarterly reports. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this communication.
